Building trust through product quality and transparency
Quality is the foundation of customer and patient trust; it is at the core of what we do to provide safe, effective products and services. All BD associates are committed to a culture of quality inspired by the customers and patients we serve.
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
A note from the Chief Quality Officer
Our products touch many lives—a friend, a family member or ourselves —at BD, our 75,000 associates around the world are committed to ensuring our products and services are safe, reliable and effective.
We believe that Quality is a journey of continuous improvement that never ends. We are constantly learning and improving our processes and ways of working. For us, continuous improvement also means being transparent. It means sharing our proactive efforts to provide the highest quality products to our customers; engaging pro-actively with regulators, suppliers and industry peers; and communicating about eventual product quality issues with the public. By doing this we are improving quality transparency at BD and fulfilling our Purpose of advancing the world of health.™
Our commitment to quality inspires trust.
— Ami Simunovich, EVP, Chief Quality & Regulatory Officer and Public Affairs
This will be achieved through customer-focused continuous improvement and maintaining an effective quality system which complies with regulatory requirements.
—Tom Polen, Chairman, CEO and President
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On our journey to Inspire Quality, we’re working together to deliver our best work. Cultivating a culture of quality and transparency is an integral part of our Environmental, Social & Governance (ESG) strategy, Together we advance. We’re proud to have placed within the 80th percentile in our first culture of quality survey.1 Learn more about our commitment to quality and transparency in our 2022 ESG report.
1 Culture of Quality survey done through Gartner. Survey completed in 2021.
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
Prevention
Develop a learning organization that proactively innovates to avoid issues.
Consistency
Less variability and enhanced simplicity means fewer mistakes and better service of patients'’ needs.
Courage
Promoting a blame-free environment encourages everyone to speak up and listen in.
Accountability
Every BD associate and team is responsible for meeting customers’ expectations. We are all accountable for quality.
Patient Focus
Patients and healthcare providers come first; there is a patient at the beginning and end of everything we do.
Our quality management system (QMS) drives consistent compliance, ensures continuous focus on patient safety, and engages our associates on our towards best-in-class quality. We are delivering meaningful enhancements to our QMS by streamlining compliance goals for our businesses and regions to ensure each site maintains certifications throughout the harmonization process and enables other BD sites to move toward certification status.
All BD sites have established quality systems compliant with industry standards and over 90% of all worldwide sites maintain certifications for the QMS. We continue to expand our footprint of Medical Device Single Audit Program (MDSAP) certifications throughout our organization.
Certifications at manufacturing, design, distribution and shared service sites:
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
BD drives transparency in quality and regulatory compliance across our organization, providing visibility to both realized and potential risks, and helps shape the external compliance environment by partnering with industry.
The Quality & Regulatory Compliance team partners with cross-functional teams to identify potential improvement opportunities, provides external industry insights and collaborates with our businesses to prepare for inspections and certifications. The Corporate Quality Audit team provides independent audits at BD prioritizing sites with higher compliance risks based on previous audit ratings, product classifications and performance, and the types of products or services the site provides.
To improve transparency of potential compliance and safety risks from recent acquisitions, we have harmonized guidelines for the identification and escalation of potential risks during due diligence and after closure. The post-acquisition process includes independent reviews of due diligence findings, planning for QMS integration and remediation of potential risks, and incorporation into the Corporate Quality Audit program.
As global regulations, standards and policies continue to evolve and modernize to keep pace with the challenges of managing public health, BD has become more agile and efficient in identifying, advocating for and assessing these changes to ensure registrations comply with current health authority expectations. Our team has centralized regulatory intelligence monitoring and linked this activity to BD’s global standards process to ensure a structured approach to conducting risk assessments, identifying gaps, remediating and ultimately updating our regulatory filings as needed.
We are also empower cross-functional teams within each business unit and region to drive accountability for incorporating new requirements from standards and regulations into the product development process.
Safety, quality and service are at the heart of how we design, manufacture and deliver products. We are focused on patient and customer safety through the predictable delivery of high-quality and effective products and services. We comply with global regulations and laws, worker safety and product performance. And we develop innovative solutions – advancing the world of health™.
At every step of the BD product development and manufacturing process, we drive risk reduction by interweaving the risk management process with quality by-design innovation and technology. BD has a cross functional Product Lifecycle Management initiative to deploy a global digital solution to manage product development, change control and integrate risk management throughout the lifecycle of our products.
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
At BD, we partner with suppliers who provide goods and services under Good Manufacturing Practice or Good Distribution Practice to manufacture our products to serve our customers around the world. Quality of these goods and services are critical to meeting our design specifications and product performance expectations. That is why BD utilizes an active approach to managing quality with our suppliers.
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
Aligned with the BD Way, "We will consistently provide superior products and services in pursuit of our purpose of advancing the world of health.” Supplier Quality is responsible for establishing and implementing global processes and essential tools to enable effective supplier qualification, performance management, and development through partnership with suppliers and key functional groups.
The supplier that provides materials, products, and quality impacting services to BD shall have an effective quality management system that complies with the requirements of applicable regulatory bodies and agencies.
The supplier shall adhere to BD specifications, supply agreements, quality agreements, purchase orders and other contractual obligations. The supplier shall establish and maintain equipment, utilities and facilities used in production, storage, and delivery of products. The supplier shall have controls with mitigation plans in place to handle potential risks. The supplier shall continuously improve quality, raw materials, components, products, processes, and systems.
The supplier shall maintain ongoing and timely communication and collaboration to ensure BD is aware of changes. This includes communication with sufficient notice period of any significant changes that the supplier’s organization may face that could affect BD product quality or supply continuity. The supplier is expected to receive written approval from a BD representative prior to making any changes to specifications (this may include, but is not limited to, changes in manufacturing processes, material, changes that impact form, fit or function of the part, change of registration status, supply chain changes, location, among others).
These changes are expected to be communicated through the BD Supplier Change Request Portal.
The supplier shall have a documented process to investigate and respond in a timely manner to all quality-related complaints and cooperate with investigations for any issues associated with the finished product or raw materials. The supplier shall have a documented process to handle non-conforming product and materials and shall notify BD of any non-conforming product shipped to BD. The supplier shall document any rework, refurbishment, or reprocessing activities as well and formally document and obtain approval for deviations from any standard and documented practices. The supplier shall notify BD of any recall resulting from failure of product or raw material and of any regulatory action for adverse event, recall, correction, etc.
The supplier shall have a management system for vendor selection, qualification, approval, and performance management of its suppliers and will ensure materials and components from its suppliers conform to specifications.
Through our memberships in organizations and trade associations, BD works to drive quality and shape the external environment through industry-wide standards and initiatives consistent with our Purpose of advancing with world of health™.
‘Alerts and Notices’ changed to ‘Recalls and Field Actions’ to be more transparent. Get the latest product communications and sign up for automatic product alerts.
The Advanced Medical Technology Association advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies.
The Medical Device Innovation Consortium is the only public-private partnership developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.
The Association for the Advancement of Medical Instrumentation is a nonprofit organization united by one important mission—the development, management, and use of safe and effective health technology and is the primary source of consensus standards, both national and international, for the medical device industry.
